Hepatitis B Vaccination (HBV) in HIV Infected Children

This study has been completed.
Sponsor:
Collaborator:
ART AIDS Charity Fund
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00886964
First received: April 22, 2009
Last updated: June 4, 2010
Last verified: June 2010

April 22, 2009
June 4, 2010
April 2009
May 2010   (final data collection date for primary outcome measure)
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886964 on ClinicalTrials.gov Archive Site
  • Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of adverse events in HBV ID group and HBV IM group [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Proportion of protective antiHBs in HIV children after protocol defining immune recovery [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hepatitis B Vaccination (HBV) in HIV Infected Children
Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children

The purpose of this study is :

  • To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly active antiretroviral therapy (HAART)
  • To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab

Hepatitis B virus (HBV) and HIV share the same route of transmission and can have co-infection. The prevalence of this co-infection was 8.7% in Thai adult[1, 2] and 12.1% in African HIV vertically transmitted children[3]. Occurrence of HBV has effects to treatment due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti HIV medication. HBV can cause chronic liver disease, cirrhosis and hepatocellular carcinoma.

In Thailand, the routine HBV vaccination program was started since 1992. Few reports in severe immune compromise HIV children has been shown to lose their expected preventive measles and hepatitis B antibody from history of scheduled vaccination even after the immune recovery by HAART[4, 5]. Limited data in of prevalence of protective hepatitis B antibody response after immune recovery in Thai HIV infected children treated with highly active antiretroviral therapy. In addition, HBV revaccination in this group of children should be considered[6].

The response of HBV revaccination intramuscularly (IM) at 0, 2 and 6 months in 63 HIV children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively[6]. Protective anti-HBs were shown in the majority of non-responders to IM HBV vaccine health care workers [21/23 (91.3%)] by two doses of intradermal route (ID)[7].

We hypothesize to see the faster and higher response of antiHBs after first dose of ID compare to IM in anti HBsAb negative HIV infected children. No randomized control trial compare antibody response between IM and ID route in HIV children after immune recovery. The benefit from this trial would be decreased the vaccine cost for resourced limited country.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: Intradermal HBV 1 course

    Dosage: 2 microgram (mcg), 0.1 ml per dose

    Location: left deltoid area x 1 injection

    Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months

  • Biological: Intramuscular HBV I course

    Dosage: 2 microgram (mcg), 0.1 ml per dose

    Location: left deltoid area x 1 injection

    Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months

  • Active Comparator: 1
    HBV ID
    Intervention: Biological: Intradermal HBV 1 course
  • Active Comparator: 2
    HBV IM
    Intervention: Biological: Intramuscular HBV I course
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected individuals
  • Age 1-18 years
  • Current CD4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years
  • Signed written informed consent
  • Negative HBs Ag, antiHBs, and antiHBc at screening visit

Exclusion Criteria:

  • Active AIDS
  • Active opportunistic infection
  • Platelet < 50,000/ mm3 at screening visit
  • History of hypersensitivity to HBV vaccine
  • Using oral steroid or immunosuppressive drugs
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00886964
HIV-NAT 107
No
Torsak Bunupuradah, HIV-NAT, The Thai Red Cross AIDS Research Center
The HIV Netherlands Australia Thailand Research Collaboration
ART AIDS Charity Fund
Principal Investigator: Torsak Bunupuradah, MD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP